The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome
Russell IJ, Crofford LJ, Leon T, et al.
Sleep Med. 2009 Jun;10(6):604-10. Epub 2009 May 1.
OBJECTIVES: Sleep disturbances are common in patients with fibromyalgia (FM). The objective of this analysis was to evaluate the effects of pregabalin on sleep in patients with FM.
METHODS: Analyses were based on two randomized, double-blind, placebo-controlled trials of pregabalin (300mg, 450mg, and 600mg daily) in adult FM patients. Sleep outcomes included the Medical Outcomes Study (MOS) Sleep Scale and a daily diary assessment of sleep quality. Treatment effects were evaluated using analysis of covariance. Clinically important differences (CID) in the Sleep Quality Diary and MOS Sleep Disturbance scores were estimated using mixed-effects models of changes in scores as a function of patients' global impressions of change. Mediation modeling was used to quantify the direct treatment effects on sleep in contrast to indirect influence of the treatment on sleep via pain.
RESULTS: A total of 748 and 745 patients were randomized in the respective studies. Patients were predominantly Caucasian females, average age 48-50 years, on average had FM for 9-10 years, and experienced moderate to severe baseline pain. Pregabalin significantly improved the Sleep Quality Diary (P<0.001), MOS Sleep Disturbance (P<0.01), MOS Quantity of Sleep (P<0.003), and MOS Sleep Problems Index scores (P<0.02) relative to placebo. Treatment effects for the 450mg and 600mg groups exceeded the estimated CID thresholds of 0.83 and 7.9 for the Sleep Quality Diary and MOS Sleep Disturbance scores, respectively. Mediation models indicated that 43-80% of the benefits on sleep (versus placebo) were direct effects of pregabalin, with the remainder resulting from an indirect effect of treatment via pain relief. CONCLUSIONS: These data demonstrate improvement in FM-related sleep dysfunction with pregabalin therapy. The majority of this benefit was a direct effect of pregabalin on the patients' insomnia, while the remainder occurred through the drug's analgesic activity.
MRI analysis of the lumbar spine: can it predict response to diagnostic and therapeutic facet procedures?
Stojanovic MP, Sethee J, Mohiuddin M, et al.
Clin J Pain. 2010;26(2):110-5.
OBJECTIVES: To determine the correlation between magnetic resonance imaging (MRI) pathology and the response to diagnostic facet medial branch block (MBB) and L5 dorsal ramus medial branch block and radiofrequency (RF) denervation of lumbar facet joints. METHODS: The medical records of 127 consecutive patients who underwent MBB for suspected zygapophysial joint pain were reviewed. The lumbar spine MRI of these patients was systematically graded by 2 musculoskeletal radiologists for loss of disc height, spinal stenosis, facet joint degeneration, and other forms of spinal pathology. RESULTS: Patients with central or foraminal spinal stenosis had statistically significant correlation with positive outcome of RF (P=0.02), but not with MBB (P=0.08). The presence of facet joint degeneration or hypertrophy was positively correlated with response to MBB (71% vs. 51%; P=0.04), but not RF. Loss of disc height did not correlate with outcome of MBB (P=0.08) and RF (P=0.29). For other spinal pathology, no significant differences were noted for either the response to diagnostic blocks or the RF denervation. Younger patients were more likely to fail MBB (P<0.01) but not RF denervation (P=0.38). DISCUSSION: Whereas some relationships were noted between MRI findings and the response to lumbar facet joint interventions, many of these correlations tended to be weak. However, this study does suggest the possibility that patients with spinal stenosis, often considered an exclusion criterion for facet interventions, may respond to RF denervation of facet joints. Prospective studies are needed to confirm these observations.
Diagnosis-Specific Management of Somatoform Disorders: Moving Beyond "Vague Complaints of Pain"
Dohrenwend A, Skillings JL.
J Pain. 2009;10(11):1128-37.
The DSM IV category, somatoform disorders, is composed of disorders that are characterized by symptom amplification-most typically, amplification of pain. Other than this commonality, there is considerable variability among the disorders in terms of etiology, course, comorbidities, and the presence or absence of insight. The heterogeneous nature of the somatoform group has led to calls to remove or radically alter the category in the next DSM revision. Despite these concerns, teaching articles addressing somatoform disorders tend to generalize across the category when making patient treatment recommendations. In this report, the authors encourage moving beyond catch phrases such as, "the somatic patient" and "vague complaints of pain," and toward accurate differential diagnosis between somatoform disorders. They argue that accurate diagnosis of somatoform disorders is both achievable and necessary to provide optimal care for this diverse population of patients. Diagnosis and patient-centered management is contrasted with more generalized treatment recommendations. PERSPECTIVE: This article highlights the appropriate diagnosis and treatment of somatoform disorders for patients with pain. In contrast to the majority of literature on the subject, the authors' emphasis the importance of differential diagnosis between somatoform disorders as well as patient-specific and diagnosis-specific treatment. The authors argue that there has been an incorrect tendency to overgeneralize across disorders, an error that is magnified by the exceptional weakness of the somatoform category.
Gamma knife radiosurgery for multiple sclerosis–related trigeminal neuralgia.
Zorro O, Labato-Polo J, Kano H, et al.
Neurology 2009;73:1149-54.
Background: Surgical options for multiple sclerosis (MS) related to trigeminal neuralgia (TN), a severe and disabling pain disorder, include percutaneous rhizotomy, stereotactic radiosurgery, or microsurgical nerve section. Our goal was to evaluate clinical outcomes after gamma knife radio-surgery (GKRS) in patients with MS with TN.
Methods: We evaluated clinical outcomes in 37 patients with TN managed over a 12-year period. The maximum TN target dose varied between 70 and 90 Gy. Seventy-eight percent of patients had failed prior surgery. In 9, GKRS was the first procedure. Median follow-up was 56.7 months (range, 6–174). Pain relief was assessed in each patient by physicians who did not participate in the surgery.
Results: Eventual complete pain relief (BNI grade I) after GKRS and reasonable pain control (BNI grade I–IIIb) after GKRS were noted in 23 patients (62.1%) and 36 patients (97.3%) at some point in their course. Reasonable pain control (BNI grade I–IIIb) after GKRS was maintained in 82.6%, 73.9%, and 54.0% of patients after 1, 3, and 5 years. Fourteen patients (37.8%) underwent a second or a subsequent procedure for residual or recurrent pain. Eight patients underwent a second GKRS, 5 underwent percutaneous glycerol rhizotomy, and 1 underwent balloon micro-compression. The complication rate after GKRS was 5.4% (new onset of nondisabling paresthesias). No patient developed dysesthesias.
Conclusions:
Gamma knife radiosurgery is the most minimally invasive surgical technique for multiple sclerosis–related trigeminal neuralgia and has low morbidity. For this reason, gamma knife radiosurgery proved to be a satisfactory management strategy for multiple sclerosis–related trigeminal neuralgia.
Economic Burden of Prescription Opioid Misuse and Abuse
Strassels SA.
J Manag Care Pharm. 2009;15(7):556-62
BACKGROUND: Prescription opioid abuse and its associated costs are a problem in the United States, with significant epidemiologic and economic consequences. The breadth and depth of these consequences are not fully understood at present.
OBJECTIVE: To summarize published, English-language biomedical evidence pertaining to the epidemiology and costs of prescription opioid analgesic misuse and abuse and to describe efforts to reduce the burden of
these problems.
METHODS: Published English-language articles on the epidemiology and economics of abuse, misuse, or diversion of prescribed opioid analgesics in the United States were identified by searching PubMed, Web of Science, the Cumulative Index to Nursing and Allied Health Literature database (CINAHL), EconLit, and PsycInfo, using (economics OR epidemiology) AND (misuse OR abuse) AND opioid as search terms or Medical Subject Heading (MeSH) terms. Article bibliographies were also searched manually for applicable papers. The search was limited to articles published from 1995 through July 2009.
RESULTS: The literature search identified 2,347 titles, of which all but 41 were excluded as not pertaining specifically to the epidemiology or economics of prescription opioid abuse or misuse in the United States. In 2006, approximately 5.2 million individuals in the United States reported using prescription analgesics nonmedically in the prior month, up from 4.7 million in 2005. The total cost of prescription opioid abuse in 2001 was estimated at $8.6 billion, including workplace, health care, and criminal justice expenditures. One study of commercially insured beneficiaries in the United States found that mean per-capita annual direct health care costs from 1998 to 2002 were nearly $16,000 for abusers of prescription and nonprescription opioids compared with approximately $1,800 for nonabusers who had at least 1 prescription insurance claim.
CONCLUSIONS: The economic burden of prescription opioid misuse and abuse is large. While the existing evidence indicates that persons who abuse or misuse prescription opioids incur higher costs and health care
resource use, differences in methods used to explore this question make estimating the actual societal burden imposed by this problem difficult. Efforts to establish and maintain a balance between access to these drugs
for legitimate pain management while decreasing the risk of abuse and misuse are critically important and include such tools as patient and provider education, patient screening, and use of technology.
Is chronic pelvic pain a comfortable diagnosis for primary care practitioners: a qualitative study.
McGowan L, Escott D, Luker K, Creed F, Chew-Graham C.
BMC Fam Pract. 2010 Jan 27;11(1):7. [Epub ahead of print]
ABSTRACT: BACKGROUND: Chronic pelvic pain (CPP) has a prevalence similar to asthma and chronic back pain, but little is known about how general practitioners (GPs) and practice nurses manage women with this problem. A clearer understanding of current management is necessary to develop appropriate strategies, in keeping with current health care policy, for the supported self-management of patients with long term conditions. The aim of this study was to explore GPs' and practice nurses' understanding and perspectives on the management of chronic pelvic pain. METHOD: Data were collected using semi-structured interviews with a purposive sample of 21 GPs and 20 practice nurses, in three primary care trusts in the North West of England. Data were analysed using the principles of Framework analysis. RESULTS: Analysis suggests that women who present with CPP pose a challenge to GPs and practice nurses. CPP is not necessarily recognized as a diagnostic label and making the diagnosis was achieved only by exclusion. This contrasts with the relative acceptability of labels such as irritable bowel syndrome (IBS). GPs expressed elements of therapeutic nihilism about the condition. Despite practice nurses taking on increasing responsibilities for the management of patients with long term conditions, respondents did not feel that CPP was an area that they were comfortable in managing. CONCLUSIONS: The study demonstrates an educational/training need for both GPs and practice nurses. GPs described a number of skills and clinical competencies which could be harnessed to develop a more targeted management strategy. There is potential to develop facilitated self- management for use in this patient group, given that this approach has been successful in patients with similar conditions such as IBS.
Understanding primary care physicians' treatment of chronic low back pain: the role of physician and practice factors.
Phelan SM, van Ryn M, Wall M, Burgess D.
Pain Med. 2009 Oct;10(7):1270-9.
BACKGROUND: An increasing number of Operation Iraqi Freedom/Operation Enduring Freedom veterans experience chronic pain. Despite treatment guidelines, there is wide variation in physicians' approaches to pain treatment, and many physicians are unsure of the best treatment approach. Research has examined factors associated with opioid prescribing, but there is little information on physician characteristics that predict patterns of clinical responses to pain. OBJECTIVES: To identify patterns in primary care physicians' treatment decisions for nonmalignant chronic pain, and identify physician and practice characteristics that predict treatment decision patterns. METHODS: A national sample of 381 primary care physicians who responded to a mailed vignette involving a veteran with chronic low back pain (LBP) were categorized into latent classes by clinical actions taken to treat the pain. The associations between newly derived treatment patterns and physician and practice characteristics were examined with multivariate models. RESULTS: Latent class analysis identified three treatment approaches: 1) Multimodal/Aggressive (14%); 2) Low Action (38%); and 3) Psychosocial/Non-Opioid (48%). In a multivariate model, treatment pattern was associated with demographic and personality factors; opioid-related attitudes, beliefs, and concerns; perceptions of the patient; availability of resources; and practice characteristics. CONCLUSIONS: There may be distinct patterns in primary care physicians' responses to patients with chronic pain. Relatively few physicians use the multimodal approach endorsed by proponents of the biopsychosocial model of pain treatment. Several physician and practice characteristics predict patterns of clinical action.
Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAP
Cherny NI, Baselga J, de Conno F, Radbruch L.
Ann Oncol. 2010 Mar;21(3):615-26.
BACKGROUND: Many patients in Europe do not receive adequate relief of pain because of excessive regulatory restrictions on the availability and accessibility of opioids. This is a major public health problem. The aim of the study is to evaluate and report on opioid availability and the legal and regulatory barriers to accessibility across the countries of Europe. METHODS: European Society for Medical Oncology and European Association for Palliative Care national representatives reported data regarding survey of opioid availability and accessibility. Formulary adequacy is evaluated relative to the World Health Organization (WHO) essential drugs list and the International Association for Hospice and Palliative Care list of essential medicines for palliative care. Overregulation is evaluated according to the guidelines for assessment of national opioid regulations of the WHO. RESULTS: Data were reported on the availability and accessibility of opioids for the management of cancer pain in 21 Eastern European countries and 20 Western European countries. Results are presented describing the availability and cost of opioids for cancer pain in each surveyed country and nine forms of regulatory restrictions. CONCLUSIONS: Using standards derived from the WHO and International Narcotics Control Board, this survey has exposed formulary deficiencies and excessive regulatory barriers that interfere with appropriate patient care in many European countries. There is an ethical and public health imperative to address these issues.
Factors Associated With Recurrent Back Pain and Cyst Recurrence After Surgical Resection of One Hundred Ninety-Five Spinal Synov
Xu R, McGirt MJ, Parker SL, et al.
Spine (Phila Pa 1976). 2010 Feb 18. [Epub ahead of print]
STUDY DESIGN.: Retrospective study. OBJECTIVE.: Compare outcomes of different treatment methods for intraspinal synovial cysts. SUMMARY OF BACKGROUND DATA.: Intraspinal synovial cysts are cited as an increasing cause of back pain and radiculopathy. To date, few studies have compared outcomes of differing treatment methods in patients with synovial cysts. METHODS.: We retrospectively reviewed 167 consecutive patients undergoing surgical management of 195 symptomatic synovial cysts at a single institution over 19 years. The incidence of postoperative mechanical back pain, radiculopathy, and cyst recurrence was compared between patients undergoing unilateral hemilaminectomy (n = 51), bilateral laminectomy (n = 39), facetectomy with in situ fusion (n = 18), and facetectomy with instrumented fusion (n = 56). RESULTS.: A total of 155 (97.5%) patients presented with radiculopathy, 132(82.5%) with mechanical back pain, 31 (20%) with neurogenic claudication, and 5 (3.2%) with bladder dysfunction. Most cysts occurred in the lumbar spine. After surgery, back and radicular pain improved in 91.6% and 91.9% patients, respectively. By a mean follow-up of 16 +/- 9 months, 36 (21.6%) patients developed recurrent back pain, 20 (11.8%) recurrent leg pain, and 5 (3%) recurrent synovial cysts. Patients undergoing laminectomy had a significantly increased cyst recurrence incidence compared to fusion groups via log-rank test (P = 0.042), and this risk was decreased to baseline with instrumented fusion on reoperation. Laminectomy was also associated with the highest increased risk of recurrent back pain in both log-rank test (P = 0.018) and proportional hazards regression (HR): 1.64 (1.00-3.45), P = 0.05. Instrumented fusion had the lowest risk for back pain recurrence. CONCLUSION.: Hemilaminectomy or laminectomy remains one of the mainstay surgical treatments for symptomatic intraspinal synovial cysts. Our experience shows that the majority of patients undergoing decompression/excision of synovial cysts will have immediate improvement in back and leg pain. However, within 2 years,patients receiving hemilaminectomy or laminectomy alone have an increased incidence of back pain and cyst recurrence. Decompression with instrumented fusion appears to be associated with the lowest incidences of cyst recurrence or back pain.
Strategies for making analgesia safer: The role for comparative effectiveness research.
Solomon DH.
Arthritis Rheum. 2010 Feb 22. [Epub ahead of print]
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